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Sonendo® Announces Health Canada Regulatory Approval for Next Generation GentleWave® G4 System

Wednesday, November 02, 2022

Sonendo, Inc., a leading dental technology company and developer of the GentleWave® System, today announced that it has received Health Canada regulatory approval for commercial sales of its recently announced GentleWave G4 System, the next generation of its innovative technology platform designed to treat tooth decay. With Sonendo's patented technology at its core, the GentleWave G4 System is designed for an optimized doctor and patient experience with a refined, simplified workflow – all while delivering the enhanced level of clean that is only available with GentleWave Technology.

Health Canada regulatory clearance expands Sonendo’s suite of products available in Canada, allowing Sonendo to bring the GentleWave G4 System’s modern design to the market, including an intuitive, user-friendly interface, battery backup and high-capacity fluid reservoirs, and multi-operatory connectivity.

The approval for sale of the GentleWave G4 System follows the recent launch of the CleanFlow™ procedure instrument in Canada. According to a recent clinical trial, 99.5% of patients experienced no pain during the GentleWave Procedure with the addition of CleanFlow Technology.

“We are excited about introducing the GentleWave G4 System to our customers and the endodontic community in Canada,” said Michael Smith, chief commercial officer at Sonendo. “We believe the GentleWave G4 System offers endodontic practices and their patients an elevated experience that also reinforces our commitment to commercial support and expansion in Canada."

The GentleWave G4 System was created with future software adaptations and evolving features in mind. An intuitive, user-friendly interface provides step-by-step guidance for practitioners and auditory cues that improve procedure awareness, reducing the need to look away from the patient during treatment. Battery backup and high-capacity fluid reservoirs decrease downtime between treatments and allow up to six procedures before refilling fluids. The system also allows multi-operatory connectivity, which means doctors can monitor multiple systems across their office, leading to improved workflow efficiency.

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